Skip to main content
OpenTrials
Completed

NCT Number: NCT04390776

Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.

The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centers of America ( Hollywood ), Hollywood, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.

Participants with any of the following acute or chronic infections or infection history:

  • Any infection requiring treatment within 2 weeks prior to the dosing visit.
  • Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
  • Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
  • Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
  • History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

Treatment and study plan

PF-06651600

Drug

PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.

Primary outcomes

  1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  2. Maximum plasma PF-06651600 concentration (C max)

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

Secondary outcomes

  1. Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  2. Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  3. Single dose plasma decay half-life (t 1/2) of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  4. Single dose Apparent Oral Clearance (CL/F) of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  5. Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600

    Time frame: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

  6. Frequency of abnormal safety laboratory tests

    Time frame: Baseline up to day 9

  7. Frequency of Adverse Events

    Time frame: Baseline up to day 35

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 18, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.